- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06911177
Yeast Mannans and Stool Frequency
April 14, 2026 updated by: University of Florida
Efficacy of Yeast Mannan Supplementation on Increasing Stool Frequency in Generally Healthy Adults: A Randomized Controlled Trial
Findings from an open-label pilot study of 20 adults suggested that supplementation with 15 g/day of yeast mannans was highly tolerable and demonstrated specific modulation of the microbiota and increased stool frequency in a subset of subjects reporting ≤1 stool per day at baseline.
The primary aim of this randomized, double-blind, controlled trial is to determine if yeast mannan supplementation at 12 g/day will increase stool frequency in generally healthy adults reporting ≤1 stool per day.
Secondary aims will determine the effect of yeast mannans on intestinal transit time, gastrointestinal symptoms, fecal microbiota composition, and urinary and fecal metabolomics.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
70
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
-
Gainesville, Florida, United States, 32611
- Department of Food Science and Human Nutrition
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Adults who report a stool frequency of ≤ 1 per day.
- Able to provide written informed consent in English.
- Willingness to consume 1 supplement (12 g of yeast mannans or control) daily for 28 days.
- Willingness to maintain their usual diet and physical activity patterns throughout the study and refrain from the consumption of any yeast-based foods (e.g. Marmite or Vegemite) or yeast extract supplements.
- Willing to comply with study procedures, including stool and urine colle
Exclusion Criteria:
- Stool frequency of < 3 per week
- Yeast allergy
- Vegan dietary pattern
- Self-reported kidney disease
- Elite athletes or long-distance runners
- Use of antibiotic drugs within 1 month of screening
- Current use of laxatives or antidiarrheal medications
- Use of other investigational products within 3 months of the screening
- Previously or currently being treated for intestinal diseases or conditions, including irritable bowel disease (i.e., IBS-D or IBS-mixed), Crohn's disease, ulcerative colitis, celiac disease, or gastrointestinal cancer.
- Previous gastrointestinal surgery (e.g., gastric bypass, fundoplication, bowel resection).
- Current cancer treatment.
- Currently pregnant.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Yeast mannan supplementation
Yeast cell wall fraction obtained from Saccharomyces cerevisiae containing mannan-oligosaccharides and mannoproteins will be supplemented at 12 g/day.
|
Yeast cell wall fraction of manno-oligosaccharides and mannoproteins supplemented at 12 g/day.
Other Names:
|
|
Placebo Comparator: Control supplementation
The control supplement, containing yeast protein, yeast extract, and maltodextrin, will be provided at 12 g/day.
|
A supplement containing yeast protein, yeast extract, and maltodextrin, provided at 12 g/day.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Defecation frequency
Time Frame: From enrollment to the end of treatment at 6 weeks.
|
Mean daily defecation frequency
|
From enrollment to the end of treatment at 6 weeks.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 17, 2025
Primary Completion (Actual)
March 16, 2026
Study Completion (Estimated)
December 31, 2026
Study Registration Dates
First Submitted
March 28, 2025
First Submitted That Met QC Criteria
April 3, 2025
First Posted (Actual)
April 4, 2025
Study Record Updates
Last Update Posted (Actual)
April 15, 2026
Last Update Submitted That Met QC Criteria
April 14, 2026
Last Verified
August 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB202500359
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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